Alabama Genomic Health Initiative Annual Report Annual Report-AGHI FINAL | Page 12

WORKING GROUPS: BIOETHICS
WORKING
GROUPS
Working Groups lead defined
areas of responsibility for the
Alabama Genomic Health Initiative
The Bioethics working group reviewed informed consent forms and procedures,
identifying bioethical issues and strategies moving forward. In addition, this working
group reviewed all recruitment materials and participant communications. Four core
values for the ethical operation of the AGHI were established: Transparency/Honesty,
Respect, Confidentiality, and Fairness. These core values were used to develop AGHI
informed consent documents for both the genotyping and whole genome sequencing
participants, which ultimately aided in being granted UAB Institutional Review Board
(IRB) approval to launch enrollment in May 2017.
Bioethics
Working Group
Leaders
The Alabama Genomic Health Initiative Bioethics working group was charged with
ensuring the highest standards of ethical review and practices in all areas of the
initiative. This includes a full review of the entire protocol to ensure high levels of
confidentiality and transparency to participants about benefits and risks associated with
participation in the AGHI. In order to meet the initiative’s goal of providing the benefits
of the AGHI to a diverse population within the state, bioethical review was provided to
ensure recruitment mechanisms and materials were appropriate to reach our state’s
diverse population.
Tom May, PhD
Faculty Investigator at
HudsonAlpha Institute
for Biotechnology
To further provide evidence of commitment to these four values, an application was
made and granted to receive the National Institutes of Health (NIH) Certificate of
Confidentiality for enrolling participants. NIH Certificates of Confidentiality “protect
against compulsory legal demands, such as court orders and subpoenas, for identifying
information or identifying characteristics of a research participant.”
Patient Navigators, responsible for providing informed consent to participants, received
bioethical training to share the understanding and the importance of bioethics and to
review key ethical points in the informed consent process. As the AGHI is extended to
additional enrollment sites, the Bioethics working group will provide bioethical training
to new staff associated with each site.
Mariko Nakano, PhD
Assistant Professor
at UAB School of
Medicine
Bioethics working group leaders are members of the variant review committee that
is charged with reviewing results from genotyping and sequencing analysis for AGHI
participants and providing scientific viewpoints as well as ethics and social values
perspectives.
Next steps:
• Develop discussion forums for bioethical issues that may arise
• Conduct research into patient and provider experiences with the AGHI. Work closely
with other working groups to identify potential ethical issues and provide consultation
and recommendations for addressing issues and developing ethical resolutions
grounded in transparency/honesty, respect, confidentiality, and fairness.
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Alabama Genomic Health Initiative Annual Report
Stephen Sodeke, PhD
Bioethicist & Professor
of Allied Health
Sciences, National
Center for Bioethics in
Research & Healthcare,
Tuskegee University
www.aghi.org
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